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Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00393523
Recruitment Status : Completed
First Posted : October 27, 2006
Results First Posted : October 12, 2009
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE October 25, 2006
First Posted Date  ICMJE October 27, 2006
Results First Submitted Date  ICMJE May 27, 2009
Results First Posted Date  ICMJE October 12, 2009
Last Update Posted Date April 12, 2017
Study Start Date  ICMJE September 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy [ Time Frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B ]
Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
To assess the quality of the priming of HBVAXPRO(TM); safety
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy [ Time Frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B ]
Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
To characterize the ability of modified process hepatitis B vaccine to act as a booster dose
Current Other Pre-specified Outcome Measures
 (submitted: April 9, 2013)
  • Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy [ Time Frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B ]
    Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of RECOMBIVAX HB™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™
  • Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy [ Time Frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B ]
    Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of ENGERIX-B™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)
Official Title  ICMJE A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO
Brief Summary To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis B
Intervention  ICMJE
  • Biological: Comparator: Modified Process Hepatitis B Vaccine
    Single dose 5 µg/0.5ml modified process hepatitis B vaccine
  • Biological: Comparator: Comparator: ENGERIX-B
    Single dose 10 µg/0.5ml ENGERIX-B
Study Arms  ICMJE
  • Active Comparator: 5 µg Modified Process Hepatitis B Vaccine Booster (Group 1)

    Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study.

    During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine (Booster Dose).

    Intervention: Biological: Comparator: Modified Process Hepatitis B Vaccine
  • Active Comparator: 10 µg ENGERIX-B™ Booster (Group 2)

    Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study.

    During this study, participants received a dose of 10µg/per 0.5 ml ENGERIX-B™ (Booster Dose)

    Intervention: Biological: Comparator: Comparator: ENGERIX-B
  • Active Comparator: 5 µg Modified Process Hepatitis B Vaccine Booster (Group 3)

    Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study.

    During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine, (Booster Dose).

    Intervention: Biological: Comparator: Modified Process Hepatitis B Vaccine
  • Active Comparator: 10 µg ENGERIX-B™ Booster (Group 4)

    Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study.

    During this study, participants received a 10µg/0.5 ml dose of ENGERIX-B™ (Booster Dose).

    Intervention: Biological: Comparator: Comparator: ENGERIX-B
  • Experimental: 5 µg Modified Process Hepatitis B Vaccine (Group 5)

    Participants did not receive a prior vaccination with a hepatitis B vaccine.

    During the study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine.

    Intervention: Biological: Comparator: Modified Process Hepatitis B Vaccine
Publications * Diez-Domingo J, Flores SA, Martin JC, Klopfer SO, Schödel FP, Bhuyan PK. A randomized, multicenter, open-label clinical trial to assess the anamnestic immune response 4 to 8 years after a primary hepatitis B vaccination series. Pediatr Infect Dis J. 2010 Oct;29(10):972-4. doi: 10.1097/INF.0b013e3181f1b3b6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2009)
1478
Original Enrollment  ICMJE
 (submitted: October 25, 2006)
1400
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Children 4 to 8 years of age
  • Complete medical records documenting receiving a previous hepatitis B vaccination during the first year of life (for Cohort A and B only)
  • Complete 3-dose vaccination with either a primary series of RECOMBIVAX HB or a primary series of ENGERIX-B (for Cohort A and B only)

Exclusion Criteria:

  • Birth mother known to be a carrier of hepatitis B virus (Cohort C only)
  • History of previous hepatitis B vaccine
  • History of vaccination with any hepatitis B vaccine (Cohort C only)
  • Known of suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (eg aluminum, yeast) recent administration of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
  • Receipt of investigational drugs or vaccines within 3 months prior to study vaccine or planned within study period
  • Impairment of immunologic function or recent use of immunomodulatory medications
  • A Combination of different hepatitis B vaccines used in the primary vaccination series (Cohort A and B only)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Spain
 
Administrative Information
NCT Number  ICMJE NCT00393523
Other Study ID Numbers  ICMJE V232-058
2006_040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP